Recently, researchers have suggested that Trasylol use may have cost 22,000 lives. Dr. Dennis Mangano released a groundbreaking study as far back as 2006, where he estimated that Trasylol use during Coronary Artery Bypass Graft surgery may have contributed to the death of over 1,000 people per month.
The use of Trasylol during heart surgeries has been linked to an increased risk of death, kidney or renal failure, heart attacks, strokes and encephalopathy among heart surgery patients.
Bayer Recalls Heart Surgery Medication Trasylol
On November 5, 2007, the U.S. Food and Drug Administration (FDA) announced that, at the agency’s request, Bayer Pharmaceuticals Corp. agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
Since that time, CBS 60 minutes has recently released, “1,000 Lives Per Month”, a groundbreaking video that has brought the Trasylol tragedy to light.
In addition, on February 21, 2008, two studies were released by the New England Journal of Medicine, wherein both studies confirm that the use of Trasylol causes an increased risk of death and kideny damage when compared to other alternative medicines or no medicine at all.
Watch the full length video below.
U.S. Food & Drug Administration (FDA) Trasylol Recall Video
Trasylol Lawsuit Update: On May 14, 2008, Bayer Pharmaceuticals notified the U.S. Food & Drug Administration (FDA) that they would be initiating a nationwide Trasylol recall.
Read the Full Transcript: Marketing of Trasylol Suspended
What is Trasylol?
Trasylol (Generic: aprotinin) is an injectable prescription drug which inhibits certain enzymes that increase the risk of bleeding during surgery and aids the body’s ability to prevent bleeding.
Normally, the drug is given to patients undergoing heart bypass surgery to control blood loss, but has also been used in other surgeries, such as hip replacement surgery.
Trasylol is manufactured by Bayer Pharmaceuticals Corporation and was approved by the Food and Drug Administration in December 1993 to reduce bleeding and the need for blood transfusion in patients undergoing heart surgery.
12/15/06: FDA Trasylol Label Change and Warning
12/15/06: MedWatch Trasylol Adverse Event Report
Must Read: FDA Trasylol Resource Page
New England Journal of Medicine Study: “The Risk Associated with Aprotinin in Cardiac Surgery”